ID

37224

Beschreibung

Brief Behavioral Therapy in Improving Sleep Disorders in Patients With Stage I-III Breast Cancer Undergoing Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT02002533

Link

https://clinicaltrials.gov/show/NCT02002533

Stichworte

Versionen (1)
  1. 08.07.19 08.07.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

8. Juli 2019

DOI

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Creative Commons BY 4.0
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Eligibility Sleep Disorder NCT02002533

Englisch

Eligibility Sleep Disorder NCT02002533

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
newly diagnosed breast cancer (stage i, ii, iii)
Beschreibung

Breast Carcinoma TNM Breast tumor staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
be receiving chemotherapy in either weekly, 2-week or 3-week cycles and have at least 6 weeks of chemotherapy treatment remaining; patients are eligible any time before chemotherapy cycle 3 if on a 2- or 3-week cycle, or cycle 4 if on a 1-week cycle; (note: use of biologics [e.g., herceptin (trastuzumab)] is permitted)
Beschreibung

Chemotherapy cycle Quantity | Chemotherapy cycle Week Quantity | Biological agents | Herceptin | trastuzumab

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1302181
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1302181
UMLS CUI [2,2]
C0439230
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C0005515
UMLS CUI [4]
C0338204
UMLS CUI [5]
C0728747
for patients on a weekly regimen, there should be at least 3 dosages of chemotherapy remaining
Beschreibung

Chemotherapy cycle Weekly | Dosage Quantity Remaining

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1302181
UMLS CUI [1,2]
C0332174
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C1527428
for patients on either a 2 week or 3 week cycle, there should be at least 2 dosages of chemotherapy remaining
Beschreibung

Chemotherapy cycle Week Quantity | Dosage Quantity Remaining

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1302181
UMLS CUI [1,2]
C0439230
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C1527428
patients will not be dropped from the study if their chemotherapy is discontinued after they are enrolled
Beschreibung

Chemotherapy Discontinue Possible

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0332149
report sleep disturbance of 8 (sum total of all 7 items) or greater on the insomnia severity index
Beschreibung

Sleep disturbances Insomnia severity index

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0037317
UMLS CUI [1,2]
C4520529
(note: this measure will be repeated again at baseline assessment)
Beschreibung

Sleep disturbance Insomnia severity index | Baseline Assessment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0037317
UMLS CUI [1,2]
C4520529
UMLS CUI [2,1]
C1442488
UMLS CUI [2,2]
C1516048
report sleep problems that began or got worse with the diagnosis of cancer or with chemotherapy; (did your sleep problems begin or get worse with the diagnosis of cancer or with chemotherapy?)
Beschreibung

Sleep disturbance Worsening Cancer diagnosis | Sleep disturbance Worsening Chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0037317
UMLS CUI [1,2]
C0332271
UMLS CUI [1,3]
C0920688
UMLS CUI [2,1]
C0037317
UMLS CUI [2,2]
C0332271
UMLS CUI [2,3]
C0392920
be able to speak and read english
Beschreibung

Able to speak English Language | Able to read English Language

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0586740
UMLS CUI [2,2]
C0376245
patients can take sleep aids (e.g., hypnotics and sedatives) for insomnia if they use sleep aids as needed; patients taking sleep aids every night are excluded; use of melatonin every night is permitted and these patients are not excluded
Beschreibung

Aid to Sleep Insomnia | Hypnotics and Sedatives | Aid to Sleep Every Night Excluded | Melatonin Every Night allowed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0718303
UMLS CUI [1,2]
C0917801
UMLS CUI [2]
C0020592
UMLS CUI [3,1]
C0718303
UMLS CUI [3,2]
C1442116
UMLS CUI [3,3]
C0332196
UMLS CUI [4,1]
C0025219
UMLS CUI [4,2]
C1442116
UMLS CUI [4,3]
C0683607
be able and willing to wear an actiwatch for the entire 24 hours of each day they are scheduled to wear it
Beschreibung

Other Coding

Datentyp

boolean

Alias
UMLS CUI [1]
C3846158
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
have diagnosis of breast cancer stage iv
Beschreibung

Breast Carcinoma TNM Breast tumor staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
have sleep problems that began before diagnosis and have not changed since diagnosis
Beschreibung

Sleep disturbances Before Diagnosis | Sleep disturbances unchanged

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0037317
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0011900
UMLS CUI [2,1]
C0037317
UMLS CUI [2,2]
C0442739
self-report or have a medical record of an unstable comorbid medical or psychiatric condition that would make it unsafe or impossible to adhere to the study protocol
Beschreibung

Comorbidity Unstable Protocol Compliance At risk | Mental condition Unstable Protocol Compliance At risk | Comorbidity Unstable Protocol Compliance Excluded | Mental condition Unstable Protocol Compliance Excluded

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C0525058
UMLS CUI [1,4]
C1444641
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C0443343
UMLS CUI [2,3]
C0525058
UMLS CUI [2,4]
C1444641
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C0443343
UMLS CUI [3,3]
C0525058
UMLS CUI [3,4]
C0332196
UMLS CUI [4,1]
C3840291
UMLS CUI [4,2]
C0443343
UMLS CUI [4,3]
C0525058
UMLS CUI [4,4]
C0332196
have a clinical diagnosis of sleep apnea or restless leg syndrome
Beschreibung

Sleep Apnea | Restless Legs Syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C0037315
UMLS CUI [2]
C0035258
be unable or unwilling to discontinue anxiolytic medication within 4 hours of intervention sessions
Beschreibung

Anti-Anxiety Agents Discontinue Unable | Anti-Anxiety Agents Discontinue Unwilling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040616
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0040616
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C0558080
take medication for sleep (e.g., hypnotics and sedatives) every night; melatonin is permitted
Beschreibung

Aid to Sleep Every Night | Hypnotics and Sedatives Every Night | Melatonin allowed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0718303
UMLS CUI [1,2]
C1442116
UMLS CUI [2,1]
C0020592
UMLS CUI [2,2]
C1442116
UMLS CUI [3,1]
C0025219
UMLS CUI [3,2]
C0683607
patients who are shift workers are excluded; shift worker is defined as someone who has irregular work and sleep hours (such as working a non-traditional schedule: e.g., 4pm-midnight or 10pm-6am; a rotating schedule e.g., alternating between day and night shifts, or starting work between 4am and 7am)
Beschreibung

Shift worker

Datentyp

boolean

Alias
UMLS CUI [1]
C0425104
have an implanted device for heart failure (e.g., pacemaker, defibrillator, left ventricular assist device, etc.)
Beschreibung

Implanted device Heart failure | Artificial cardiac pacemaker | Defibrillator | Left ventricular assist device

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021102
UMLS CUI [1,2]
C0018801
UMLS CUI [2]
C0030163
UMLS CUI [3]
C0180307
UMLS CUI [4]
C0181598
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Ähnliche Modelle

Eligibility Sleep Disorder NCT02002533

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma TNM Breast tumor staging
Item
newly diagnosed breast cancer (stage i, ii, iii)
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Chemotherapy cycle Quantity | Chemotherapy cycle Week Quantity | Biological agents | Herceptin | trastuzumab
Item
be receiving chemotherapy in either weekly, 2-week or 3-week cycles and have at least 6 weeks of chemotherapy treatment remaining; patients are eligible any time before chemotherapy cycle 3 if on a 2- or 3-week cycle, or cycle 4 if on a 1-week cycle; (note: use of biologics [e.g., herceptin (trastuzumab)] is permitted)
boolean
C1302181 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1302181 (UMLS CUI [2,1])
C0439230 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0005515 (UMLS CUI [3])
C0338204 (UMLS CUI [4])
C0728747 (UMLS CUI [5])
Chemotherapy cycle Weekly | Dosage Quantity Remaining
Item
for patients on a weekly regimen, there should be at least 3 dosages of chemotherapy remaining
boolean
C1302181 (UMLS CUI [1,1])
C0332174 (UMLS CUI [1,2])
C0178602 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1527428 (UMLS CUI [2,3])
Chemotherapy cycle Week Quantity | Dosage Quantity Remaining
Item
for patients on either a 2 week or 3 week cycle, there should be at least 2 dosages of chemotherapy remaining
boolean
C1302181 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0178602 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1527428 (UMLS CUI [2,3])
Chemotherapy Discontinue Possible
Item
patients will not be dropped from the study if their chemotherapy is discontinued after they are enrolled
boolean
C0392920 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0332149 (UMLS CUI [1,3])
Sleep disturbances Insomnia severity index
Item
report sleep disturbance of 8 (sum total of all 7 items) or greater on the insomnia severity index
boolean
C0037317 (UMLS CUI [1,1])
C4520529 (UMLS CUI [1,2])
Sleep disturbance Insomnia severity index | Baseline Assessment
Item
(note: this measure will be repeated again at baseline assessment)
boolean
C0037317 (UMLS CUI [1,1])
C4520529 (UMLS CUI [1,2])
C1442488 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
Sleep disturbance Worsening Cancer diagnosis | Sleep disturbance Worsening Chemotherapy
Item
report sleep problems that began or got worse with the diagnosis of cancer or with chemotherapy; (did your sleep problems begin or get worse with the diagnosis of cancer or with chemotherapy?)
boolean
C0037317 (UMLS CUI [1,1])
C0332271 (UMLS CUI [1,2])
C0920688 (UMLS CUI [1,3])
C0037317 (UMLS CUI [2,1])
C0332271 (UMLS CUI [2,2])
C0392920 (UMLS CUI [2,3])
Able to speak English Language | Able to read English Language
Item
be able to speak and read english
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0586740 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
Aid to Sleep Insomnia | Hypnotics and Sedatives | Aid to Sleep Every Night Excluded | Melatonin Every Night allowed
Item
patients can take sleep aids (e.g., hypnotics and sedatives) for insomnia if they use sleep aids as needed; patients taking sleep aids every night are excluded; use of melatonin every night is permitted and these patients are not excluded
boolean
C0718303 (UMLS CUI [1,1])
C0917801 (UMLS CUI [1,2])
C0020592 (UMLS CUI [2])
C0718303 (UMLS CUI [3,1])
C1442116 (UMLS CUI [3,2])
C0332196 (UMLS CUI [3,3])
C0025219 (UMLS CUI [4,1])
C1442116 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
Other Coding
Item
be able and willing to wear an actiwatch for the entire 24 hours of each day they are scheduled to wear it
boolean
C3846158 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Breast Carcinoma TNM Breast tumor staging
Item
have diagnosis of breast cancer stage iv
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Sleep disturbances Before Diagnosis | Sleep disturbances unchanged
Item
have sleep problems that began before diagnosis and have not changed since diagnosis
boolean
C0037317 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
C0037317 (UMLS CUI [2,1])
C0442739 (UMLS CUI [2,2])
Comorbidity Unstable Protocol Compliance At risk | Mental condition Unstable Protocol Compliance At risk | Comorbidity Unstable Protocol Compliance Excluded | Mental condition Unstable Protocol Compliance Excluded
Item
self-report or have a medical record of an unstable comorbid medical or psychiatric condition that would make it unsafe or impossible to adhere to the study protocol
boolean
C0009488 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C1444641 (UMLS CUI [1,4])
C3840291 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C1444641 (UMLS CUI [2,4])
C0009488 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0332196 (UMLS CUI [3,4])
C3840291 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
C0332196 (UMLS CUI [4,4])
Sleep Apnea | Restless Legs Syndrome
Item
have a clinical diagnosis of sleep apnea or restless leg syndrome
boolean
C0037315 (UMLS CUI [1])
C0035258 (UMLS CUI [2])
Anti-Anxiety Agents Discontinue Unable | Anti-Anxiety Agents Discontinue Unwilling
Item
be unable or unwilling to discontinue anxiolytic medication within 4 hours of intervention sessions
boolean
C0040616 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0040616 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Aid to Sleep Every Night | Hypnotics and Sedatives Every Night | Melatonin allowed
Item
take medication for sleep (e.g., hypnotics and sedatives) every night; melatonin is permitted
boolean
C0718303 (UMLS CUI [1,1])
C1442116 (UMLS CUI [1,2])
C0020592 (UMLS CUI [2,1])
C1442116 (UMLS CUI [2,2])
C0025219 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
Shift worker
Item
patients who are shift workers are excluded; shift worker is defined as someone who has irregular work and sleep hours (such as working a non-traditional schedule: e.g., 4pm-midnight or 10pm-6am; a rotating schedule e.g., alternating between day and night shifts, or starting work between 4am and 7am)
boolean
C0425104 (UMLS CUI [1])
Implanted device Heart failure | Artificial cardiac pacemaker | Defibrillator | Left ventricular assist device
Item
have an implanted device for heart failure (e.g., pacemaker, defibrillator, left ventricular assist device, etc.)
boolean
C0021102 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
C0030163 (UMLS CUI [2])
C0180307 (UMLS CUI [3])
C0181598 (UMLS CUI [4])
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